Quality Engineer

Position Overview
This position is for a Quality Engineer, reporting to the Sr. Quality Manager, with primary responsibility for Process Validation activities in manufacturing. This person will work with cross functional teams to determine validation activities required for projects as well as engineering and process changes. This person will support the validation roadmap for the site. This role will also support Design Transfer/Change Control projects as needed. This role requires excellent organizational skills, analytical problem-solving skills, the ability to effectively communicate at a technical level as well as with management, and in-depth understanding of quality system requirements.
Responsibilities
This position will be responsible for being the Quality Assurance lead for Validation as well as supporting Design Transfer and other change projects, including engineering and process change projects.
The person in this role will:
• Support validation process through protocol drafting, approval and execution and providing validation training and guidance
• Chair Process Change Review Board and participate in Validation Review Board meetings
• Participate in Design Transfer/Change Control projects as the Quality Assurance Core Team Lead
• Lead improvement initiatives for Quality Assurance
• Independently perform full range of standard work
• Identify and resolve more complex problems and apply problems-solving skills in order to handle most situations
• Use statistical analysis and risk management techniques
• Provide guidance for process changes, including guidance on validation requirements
• Lead CAPA investigations
Required Knowledge/Skills, Education, and Experience
• In depth working knowledge and practical application of process validation requirements (IQ/OQ/PQ) and TMV, with ability to develop and support creation of protocols and reports
• Proven ability to lead projects
• In-depth knowledge of requirements related to ISO 13485 and FDA QSR
• Strong knowledge of Risk Management and Design Controls/Design Transfer/Change Control
• Experience with product transfers and new product development projects
• Experience with problem solving techniques and CAPA investigations
• Strong organizational skills and ability to prioritize
• Experience working in medical device or regulated industry
• Proficient with Microsoft Excel, including use of pivot tables
• Perform statistical analysis using standard software such as Minitab
• Ability to make decisions and communicate effectively to multiple levels
Preferred Knowledge/Skills, Education, and Experience
• Bachelor's degree in Science or Engineering field of study
• Certified Quality Engineer (CQE) Six Sigma Certification experience preferred
• 5-8 years of successful experience in medical device and quality engineering, and successful demonstration of Responsibilities and Knowledge as listed above